Fomepizole
As of the edition of 20 October 2026, Fomepizole is a small molecule: marketed, first approved in 1997 (US); acts on ADH1A, ADH1B and ADH1C; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Antizol
- First approved
- 4 December 1997 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Takeda; 3 holders in all
- Registered trials
- 5, 1 stopped early
- Disease areas
- Chemically induced; Digestive system; Eye; Inherited and neonatal; Mental health
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Endo.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Fomepizole.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| All trials | 5 |